K2M receives FDA clearance for Cayman United Plate System

Following the completion of its first surgical cases, K2M has received Food and Drug Administration (FDA) 510(k) clearance and a CE mark for its Cayman United Plate System.

The Cayman United Plate System is designed for rigid fixation to K2M’s Cascadia Lateral 3D Interbody System, which features Lamellar 3D Titanium Technology. It is the only 3D-printed cage with modular fixation capabilities, a company press release informs.

Cayman United’s single level, one- and two-hole plate configurations match all Cascadia Lateral 3D height and lordosis options, allowing surgeons to customise the construct using a lateral approach. Single-level plate sizes are designed to minimise retraction required for placement. An assembly alignment feature keys into the Cascadia implants to resist rotation.

K2M’s Lamellar 3D Titanium Technology uses a 3D-printing method to produce the Cascadia implants from a titanium powder. The company uses a high-energy laser beam to incorporate a rough surface architecture that preclinical data have associated with the stimulation of bone growth.

“The Cayman United Plate System, which firmly fixates to K2M’s Cascadia Lateral 3D implants, is a notable advancement,” says Robert Lee, a spine surgeon at Royal National Orthopaedic Hospital NHS Trust (Stanmore, UK). “Its streamlined technique and versatile insertion options provide an elegant solution for my minimally invasive lateral cases, while also utilising a 3D-printed device to encourage bony integration throughout the implant.”